No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00887517399779 | 6942044 | CoRoent® XLR, 20x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
2 | 00887517399700 | 6941844 | CoRoent® XLR, 18x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
3 | 00887517399335 | 6941644 | CoRoent® XLR, 16x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
4 | 00887517398765 | 6941444 | CoRoent® XLR, 14x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
5 | 00887517398499 | 6941244 | CoRoent® XLR, 12x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
6 | 00887517398420 | 6941044 | CoRoent® XLR, 10x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
7 | 00887517398055 | 6932088 | CoRoent® XLR, 20x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
8 | 00887517397683 | 6931888 | CoRoent® XLR, 18x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
9 | 00887517397256 | 6931688 | CoRoent® XLR, 16x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
10 | 00887517396822 | 6931488 | CoRoent® XLR, 14x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
11 | 00887517396457 | 6931288 | CoRoent® XLR, 12x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
12 | 00887517395641 | 6922088 | CoRoent® XLR, 20x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
13 | 00887517395634 | 6922044 | CoRoent® XLR, 20x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
14 | 00887517395269 | 6921888 | CoRoent® XLR, 18x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
15 | 00887517395252 | 6921844 | CoRoent® XLR, 18x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
16 | 00887517394880 | 6921688 | CoRoent® XLR, 16x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
17 | 00887517394873 | 6921660 | CoRoent® XL Wide, 16x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
18 | 00887517394866 | 6921655 | CoRoent® XL Wide, 16x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
19 | 00887517394859 | 6921650 | CoRoent® XL Wide, 16x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
20 | 00887517394842 | 6921645 | CoRoent® XL Wide, 16x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
21 | 00887517394835 | 6921644 | CoRoent® XLR, 16x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
22 | 00887517394569 | 6921488 | CoRoent® XLR, 14x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
23 | 00887517394552 | 6921460 | CoRoent® XL Wide, 14x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
24 | 00887517394545 | 6921455 | CoRoent® XL Wide, 14x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
25 | 00887517394538 | 6921450 | CoRoent® XL Wide, 14x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
26 | 00887517394521 | 6921445 | CoRoent® XL Wide, 14x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
27 | 00887517394514 | 6921444 | CoRoent® XLR, 14x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
28 | 00887517394149 | 6921288 | CoRoent® XLR, 12x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
29 | 00887517394132 | 6921260 | CoRoent® XL Wide, 12x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
30 | 00887517394125 | 6921255 | CoRoent® XL Wide, 12x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
31 | 00887517394118 | 6921250 | CoRoent® XL Wide, 12x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
32 | 00887517394101 | 6921245 | CoRoent® XL Wide, 12x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
33 | 00887517393791 | 6921244 | CoRoent® XLR, 12x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
34 | 00887517393722 | 6921088 | CoRoent® XLR, 10x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
35 | 00887517393715 | 6921060 | CoRoent® XL Wide, 10x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
36 | 00887517393708 | 6921055 | CoRoent® XL Wide, 10x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
37 | 00887517393395 | 6921050 | CoRoent® XL Wide, 10x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
38 | 00887517393388 | 6921045 | CoRoent® XL Wide, 10x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
39 | 00887517393371 | 6921044 | CoRoent® XLR, 10x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
40 | 00887517393333 | 6920860 | CoRoent® XL Wide, 8x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
41 | 00887517393326 | 6920855 | CoRoent® XL Wide, 8x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
42 | 00887517393319 | 6920850 | CoRoent® XL Wide, 8x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
43 | 00887517393302 | 6920845 | CoRoent® XL Wide, 8x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
44 | 00887517392961 | 6916860 | CoRoent® XL, 16x18x60mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
45 | 00887517392954 | 6916855 | CoRoent® XL, 16x18x55mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
46 | 00887517392947 | 6916850 | CoRoent® XL, 16x18x50mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
47 | 00887517392930 | 6916845 | CoRoent® XL, 16x18x45mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
48 | 00887517392923 | 6916840 | CoRoent® XL, 16x18x40mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
49 | 00887517392916 | 6916260 | CoRoent® XL Wide, 16x22x60mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
50 | 00887517392909 | 6916255 | CoRoent® XL Wide, 16x22x55mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00817100020438 | OPALACQ-02-04-00-000 | Software, Opal Acquire Image Acquisition Software. | Konica Minolta Software Opal Acquire | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
2 | 00817100020421 | OPALACQ-02-03-04-000 | Software, Opal Acquire Image Acquisition Software | Konica Minolta Software Opal Acquire | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
3 | 00817100020414 | OPALACQ-04-01-00-000 | Software, Opal Acquire Image Acquisition Software. | Konica Minolta SW Opal (Acquire), 20/20 Opal (Acquire) | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
4 | 00817100020193 | EXA 01-04-000 | EXA is a software device that receives digital images and data from various sour EXA is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.Lossy compressed mammographic images are not intended for diagnostic review. | Konica Minolta SW (PACS) Exa | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
5 | 00817100020186 | OPALACQ 04-02-01-000 | Software, Opal Acquire Image Acquisition Software. | Konica Minolta SW (Acquire) Opal, 20/20 Opal (Acquire) Vizion | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
6 | 00817100020100 | RF6000 | Platinum Radiographic / Fluoroscopic system 90/90 DRF43 FL with generator and X-Ray tube. | Dynamic DR Room | KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | |
7 | 00817020020808 | M811000 | SmartEP Software | INTELLIGENT HEARING SYSTEMS CORP. | ||
8 | 00817020020310 | M014911 | USB to Electrical Stimulation Box Cable | INTELLIGENT HEARING SYSTEMS CORP. | ||
9 | 00817020020303 | M014920 | Electrical Stimulator Probe | INTELLIGENT HEARING SYSTEMS CORP. | ||
10 | 00817020020297 | M014910 | Electrical Stimulation Box | INTELLIGENT HEARING SYSTEMS CORP. | ||
11 | 00817020020051 | M011110 | Universal Smart Box | INTELLIGENT HEARING SYSTEMS CORP. | ||
12 | 00816847022606 | Fluoroscopic Insert | 351-80-11 | Single use stainless steel tube insert to be used for fluoroscopic feedback for Single use stainless steel tube insert to be used for fluoroscopic feedback for alignment of cutting guides. | Vantage PSI | 3D SYSTEMS, INC. |
13 | 00816847022590 | Anatomical Model | 351-80-90 | A three dimensional physical model depicting patient specific anatomy. To be us A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. | Vantage PSI | 3D SYSTEMS, INC. |
14 | 00816847022583 | Tibia Cutting Guide | 351-80-10 | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | Vantage PSI | 3D SYSTEMS, INC. |
15 | 00816847022576 | Talus Cutting Guide | 351-80-00 | A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. | Vantage PSI | 3D SYSTEMS, INC. |
16 | 00816847022569 | 1.0.2 | The D2P software is a stand-alone modular software package that provides advance The D2P software is a stand-alone modular software package that provides advanced visualization of DICOM imaging data. This modular package includes, but is not limited to the following functions:- DICOM viewer and analysis- Automated segmentation- Editing and pre-printing- Seamless integration with 3D Systems printers- Seamless integration with 3D Systems software packages- Seamless integration with Virtual Reality visualization for non-diagnostic use | D2P | 3D SYSTEMS, INC. | |
17 | 00816847021470 | 1.0.2 | The D2P software is a stand-alone modular software package that allows easy to u The D2P software is a stand-alone modular software package that allows easy to use and quick digital 3D model preparation for printing or use by third party applications. The software is aimed at usage by medical staff, technicians, nurses, researchers or lab technicians that wish to create patient specific digital anatomical models for variety of uses such as training, education, and pre-operative surgical planning. The patient specific digital anatomical models may be further used as an input to a 3D printer to create physical models for visual, non-diagnostic use. This modular package includes, but is not limited to the following functions:- DICOM viewer and analysis- Automated segmentation- Editing and pre-printing- Seamless integration with 3D Systems printers- Seamless integration with 3D Systems software packages | D2P | 3D SYSTEMS, INC. | |
18 | 00816847021463 | Resected Anatomical Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
19 | 00816847021456 | Resected Full Skull Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
20 | 00816847021371 | 2.0.1. | PROcedure Rehearsal Studio | Image segmentation system for the transfer of imaging information from a medical Image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for surgical planning. | PROcedure Rehearsal Studio | 3D SYSTEMS, INC. |
21 | 00816847021364 | Metal Slot (45mm) | Reusable accessory Cutting insert | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
22 | 00816847021357 | Metal Slot (40mm) | Reusable accessory Cutting insert | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
23 | 00816847021340 | Metal Slot (35mm) | Reusable accessory Cutting insert | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
24 | 00816847021333 | Metal Slot (25mm) | Reusable accessory Cutting insert | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
25 | 00816847021326 | Drill Guide (1.1 mm & 2.3 mm Screws) | Reusable accessory drill guide | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
26 | 00816847021319 | Drill Guide (1mm Pre-Drill) | Reusable accessory drill guide | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
27 | 00816847021302 | Drill Guide (2.3 mm & 2.7 mm Screws) | Reusable accessory drill guide | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
28 | 00816847021296 | Drill Guide (2.0 mm Screws) | Reusable accessory drill guide | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
29 | 00816847021289 | Implant Template | A three dimensional physical model depicting patient specific anatomy. To be us A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize patient anatomy. Model may also be used to pre-contour off-the-shelf implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
30 | 00816847021272 | Bone Graft Template | A three dimensional physical model depicting patient specific anatomy. To be us A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize patient anatomy. Model may also be used to pre-contour off-the-shelf implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
31 | 00816847021265 | Graft Pre-Contouring Template | A three dimensional physical model depicting patient specific anatomy. To be us A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize patient anatomy. Model may also be used to pre-contour off-the-shelf implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
32 | 00816847021258 | Resected Mandible Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
33 | 00816847021241 | Resected Maxilla Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
34 | 00816847021234 | Perfected Maxilla/Mandible 2-Piece Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
35 | 00816847021227 | Perfected Maxilla/Mandible 1-Piece Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
36 | 00816847021210 | Perfected Full Skull Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
37 | 00816847021203 | Perfected Mandible Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
38 | 00816847021197 | Perfected Maxilla Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
39 | 00816847021180 | Perfected Anatomical Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
40 | 00816847021173 | Mirrored Anatomical Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
41 | 00816847021166 | Repositioned Maxilla/Mandible 2-Piece Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
42 | 00816847021159 | Repositioned Maxilla/Mandible 1-Piece Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
43 | 00816847021142 | Repositioned Full Skull Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
44 | 00816847021135 | Repositioned Mandible Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
45 | 00816847021128 | Repositioned Maxilla Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
46 | 00816847021111 | Repositioned Anatomical Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
47 | 00816847021104 | Reconstructed Maxilla/Mandible 2-Piece Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
48 | 00816847021098 | Reconstructed Maxilla/Mandible 1-Piece Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. | |
49 | 00816847021081 | Reconstructed Full Skull Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System, VSP Cranial | 3D SYSTEMS, INC. | |
50 | 00816847021074 | Reconstructed Mandible Model | A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants. | VSP System | 3D SYSTEMS, INC. |